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Fdanewsdevicedailybulletin

March 9, 2005

Vol. 2 No. 48

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HAp Nano Stent Coating Shows Excellent Biocompatibility, Safety

MIV Therapeutics (MIVT) , a developer of next-generation drug-eluting coatings that inhibit the rejection of implanted medical devices, has announced the successful completion of pilot preclinical studies of hydroxyapatite (HAp) coated stents in pig coronary arteries.

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Dade Behring Test Gets FDA Approval

Dade Behring, a maker of blood-testing kits, has received FDA approval to use its NT-proBNP test on the company's Stratus CS Acute Care Diagnostics System.

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AKonya Eliminator Plus Enters U.S., European Markets

IDev Technologies has received 510(k) clearance from the FDA to market the AKonya Eliminator Plus Mechanical Thrombectomy Device in the U.S. and has commercially released the CE-Marked device into the European market, the company said.

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COMPASS-HF Shows Monitor Reduces Heart Failure Hospital Events

Medtronic has announced results of the COMPASS-HF (Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure) clinical trial that were presented at the American College of Cardiology Annual Scientific Session.

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Abbott Introduces Automated Hepatitis C Test for AxSYM System

Abbott announced the availability of a fully automated hepatitis C virus (HCV) test in the U.S. for its widely-used AxSYM automated immunoassay instrument system.

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Longport Terminates Distribution Agreement

Longport, a medical technology specialist in high resolution ultrasound imaging, has terminated its distribution agreement with U.S. MedSys.

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Fisher Scientific to Divest Atos Medical AB

Fisher Scientific International has signed a definitive agreement to sell Atos Medical AB, a manufacturer of ear, nose and throat medical devices with 2004 sales totaling $35 million, to Nordic Capital for $110 million in cash.

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Delphi Signs Licensing Agreement for Respiratory Care Technologies

Delphi Medical Systems, a subsidiary of Delphi, expanded its collaboration with SRI International, a non-profit public benefit organization, to develop a patented, respiratory care family of devices for use primarily at home and in alternate sites.

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Nanogen Expands European Distribution Network

Nanogen, developer of advanced diagnostic products, announced its subsidiary SynX signed five new European distributors for its point-of-care products.

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MASTER I Risk Stratification Study Completes Enrollment

Cambridge Heart announced the completion of enrollment in the MASTER I Clinical Trial (Microvolt T-Wave AlternanS TEsting for Risk Stratification of Post MI Patients).

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Third Round Adds $16 Million in Funding for Nanomix

Nanoelectronic detection device developer Nanomix says it raised $16 million in a third round of funding.

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Six-Month Data Supports Further Study of Clip Device

After the leaky mitral valves in their hearts were repaired nonsurgically with a tiny, catheter-fed clip, nearly all -- over 90 percent -- of the patients whose mitral regurgitation was significantly reduced one month after receiving the clip maintained the reduction at six months.

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Arcturus Bioscience Appoints Chief Executive Officer

Arcturus Bioscience, has announced that Antonius Schuh has been appointed chief executive officer and will be elected a member of the company's board of directors.

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